EarlySense® Central Display Unit

Basic Information

• Brand Name: EarlySense® Central Display Unit
• Primary DI: 07290016169140
• Version / Model: N/A
• Catalog Number: AME-002500 US
• Company Name: EARLYSENSE LTD
• Labeler DUNS: 649822657
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-16
• Public Version: 4
• Public Version Date: 2020-05-19
• Public Version Status: Update
• Public Device Record Key: 67151b0e-345a-44de-ad9f-e1534514b783

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MSX	System,Network And Communication,Physiological Monitors	Cardiovascular	870.2300	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38470	Centralized patient monitor	A mains electricity (AC-powered) device designed to receive continuous, interval and/or spot-check physiological data (e.g., vital signs) from one or more bedside patient monitor(s) (not included) to display this information at a central patient monitoring station where staff can monitor multiple patients simultaneously. It is comprised of hardware with integrated software and is especially used in critical care settings, producing visible and/or audible signals/alarms when adverse conditions are registered. Additional features may include Holter/ST-segment monitoring and patient data transfer [e.g., into an electronic medical record (EMR)].	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016169140	GS1

Premarket Submissions

Submission Number	Supplement Number
K151006	000